Tokyo, Oct. 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059329) titled 'Tissue Proximity Indication-Guided Pulsed Field Ablation for Atrial Fibrillation: A Multicenter observational Study' on Oct. 8.
Study Type:
Observational
Primary Sponsor:
Institute - Nihon University School of Medicine Itabashi Hospital
Condition:
Condition - Ftrial Fibrillation
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Pulsed field ablation (PFA) has recently gained widespread attention as a novel therapeutic modality for atrial fibrillation (AF). The VARIPULSE catheter system, designed specifically for PFA, incorporates a Tissue Proximity Indication (TPI) module that enables objective assessment of catheter-tissue contact through impedance-based feedback. This study aims to evaluate the safety and efficacy of TPI-guided ablation and to validate its procedural safety in real-world clinical settings.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 18
years-old
=18 years. 2) Scheduled for a first catheter ablation for atrial fibrillation. 3) Use of the VARIPULSE catheter system (software Version 8). 4) Ablation performed under a TPI-guided strategy. 5) Ability and willingness to comply with planned follow-up (ECG/Holter, etc.).
Key exclusion criteria - Prior left atrial ablation. 2) Long-standing persistent or permanent AF. 3) Severe valvular disease. 4) End-stage renal disease on dialysis. 5) Active malignancy with poor prognosis. 6) Contraindications to oral anticoagulation. 7) Inability to provide informed consent. 8) Severe cognitive/psychiatric disorder precluding participation. 9) Left atrial diameter >50 mm. 10) LVEF 180 mmHg). 14) Pregnancy or lactation. 15) Life expectancy <12 months. 16) Deemed unsuitable by the investigator.
Target Size - 300
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 06 Month 10 Day
Anticipated trial start date - 2025 Year 11 Month 01 Day
Last follow-up date - 2028 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067846
Disclaimer: Curated by HT Syndication.
